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To observe the effiacay, safety and risk of developing diabetes, review the patients chars who had administrated or neet to administrate the Pravafenix cap for enroll period, it is an prospective observational study that only collect the collectable information follwoing the hospital visiting date from enroll point to information collecting date. There is no extra visit for this study.
Observe the data which has been collected for 3 yearts every year from enroll point, if the patients agree to be participated in this study and are suitable in inclusion/exclusion criteria.
If the lipid-lowering drugs(only Ezetimibe is possible) is add-on the Pravafenix Cap administrating period, it will be analyzed by laering analysis separately. But, the reason why it is add-on to have to be written on e-CRF.
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence and mortaity about the cardiovascular disease case for 3 years from administrating the Pravafenix Cap. | (Occurence of the MACE for 3 years after aministrating the Pravfenix Cap) | For 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the diabetic index (Before/after the administration of the Pravafenix Cap) | FBS, HbA1c | For 3 years |
| Variation of lipid parameter(Before/after the administration of the Pravafenix Cap) |
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Inclusion Criteria:
Among the patients with artheriosclerotic cardiovascular heart failure who have been hopitalized or visited the hospital.
Men or Women over 20 years old
Patients who had already administrated or need to administrate the Pravafenix Cap
Patients who have abnormal opinion(dyslipidemia) about LDL-C, TG, HDL-C at the enroll point
Voluntary written informed consent to study participation
Exclusion Criteria:
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Patients who have dyslipidemia, already administrated or need to administrate the Pravafenix Cap.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min-Kyung Kwon, Manager | Contact | 82-2-6202-7104 | mkkwon@yypharm.co.kr | |
| Seul-Gi Ha, Ass. Manager | Contact | 82-2-6202-7105 | sgha@yypharm.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Myung-Ho Jeong, Ph.D | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam national university hospital | Gwangju | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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TC, LDL-C, TG, HDL-C
| For 3 years |
| Variation of inflammatory index(Before/after the administration of the Pravafenix Cap) | hs-CRP | For 3 years |
| Occurrence of the major clinical events | eventsBefore/after the administration of the Pravafenix Cap. | For 3 years |